Current Research Studies

The Family Allergy & Asthma Research Institute is currently recruiting individuals who have allergic and asthmatic conditions for our active studies listed below. You do not need to be a current patient of Family Allergy & Asthma to participate in a research study.

If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.

ALK PT-01 (PEANUT ALLERGY)

The purpose of the study is to investigate at which dose to start, and how to safely raise the dose of a peanut allergy drug in adults, teenagers, and children with peanut allergy.
There are 2 parts in this study.
- Part 1 is being completed first to determine the most suitable starting dose for a person with peanut allergy.
- The results from part 1 will decide the starting dose in part 2 of the study. The study drug is a sublingual (under the tongue) tablet immunotherapy.
Please note, part 1 of the study is adults only.
Study last 7-13 weeks with 5 clinic visits and 12 telephone calls.

NOVARTIS LOU064 (PEANUT ALLERGY)

The purpose of the study is to investigate the efficacy, safety and tolerability of remibrutinib (oral tablet) at multiple dose levels verses placebo in adult participants (18-55) with peanut allergy.
Subject’s must be > 18 to < 55 years of age with a peanut allergy.
Study lasts about 3 months with 10 clinic visits and contacted by phone for safety follow ups.

NOVARTIS CQGE031G (PEANUT ALLERGY)

Ligelizumab is a humanized, IgG1-subtype monoclonal antibody, which is a highly potent inhibitor of human IgE.
The purpose of the study is to evaluate the safety and clinical efficacy of ligelizumab in decreasing the sensitivity to peanuts in patients with peanut allergy.

Eligibility:

Subject’s must be > 6 to < 55 years of age. Patients must have a history of allergies to peanuts or peanut-containing foods. Body weight > 20 kg.
Study drug is given subcutaneous every 4 weeks. (Each subject will receive 2 injections)
Subject’s will undergo DBPCFC (Double Blind Placebo Controlled Food Challenge) at week 12 and week 52. SPT (Skin Prick Test) at baseline, week 16, week 56 and week 68.
Inclusion Positive SPT > 4mm, Positive peanut specific IgE >6 at screening, Positive peanut DBPCFC <100 mg of peanut protein at screening visit 2, part 1 and part 2 DBPCFC.
Screening 4 weeks, Treatment 52 weeks, Follow-up 16 weeks.

OCTOPHARMA NORM-01 (PID)

The study will assess the efficacy of Newnorm in preventing serious bacterial infections in patients with Primary Immunodeficiency.

Eligibility:

Age > 12 years and < 75 years. Documented confirmed diagnosis of PID. At least 12-weeks of regular treatment before the screening visit.
Bass mass index must be > 40 kg.
Duration of study is 52 weeks. Subject will be provided with study product and supplies for infusions at home, when not completed at the study site.

TARGET DERM (AD/CSU) OBSERVATIONAL

This study does not include any study drug. * Please note this study is only approved at the SE, EE, BC, and FC office*.

Eligibility:

Adults and children (all ages) that have been prescribed any dermatologic treatment for a physician-confirmed Immune Mediated Inflammatory Skin Condition.
The purpose of this research is to observe patients with Immune-mediated Inflammatory Skin Conditions in a ‘real world’ setting and create an IMISC patient registry to better understand these diseases and how they are treated.
Enrolling patients in two cohorts, moderate to severe Atopic Dermatitis and Chronic Spontaneous Urticaria.
Medical Records for the past 3 years will be collected. Future medical records will be collected every 6 to 12 months.
The study will last for as long as the subject agrees to allow medical record collection. Subject will complete optional questionnaires via e-mail.

ASTRAZENECA KALOS (ASTHMA)

This study will compare BGF MDI taken twice daily to BFF MDI taken twice daily and Symbicort.

Eligibility:

Age > 18 to < 80 years. Patients will need to have a documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (oral or IV) and any combination for at least 3 days, associated physician visit, hospitalization, or ER visit due to asthma in the last 12 months.
The duration of the study is at least 30 weeks and may continue for as long as 64 weeks (approximately 7 months to 15 months). A minimum of 7 office visits and a maximum of 11.
Each visit will take between 4 to 5 hours. Randomized subject visits will be every 4 weeks.
Patients will switch from their routine asthma medications.

TARGET-RWE (ASTHMA) OBSERVATIONAL

This study does not include any study drug. * Please note this study is only approved at the SE, EE, BC, and FC office*.

Eligibility:

Adult and children currently being managed or treated for chronic disease under study.
Enrolled participants must have severe asthma and are currently being treated with biologic therapy.
The purpose of this research is to observe patients with various chronic diseases in a ‘real world’ setting to determine if treatments and other interventions that may be recommended by doctors can affect the disease.
Medical Records for the past 3 years will be collected. Future medical records will be collected every 12 months. Asthma Control Test questionnaire completed once a year at standard of care appointment.
The study is expected to last 10 years.

ASTRAZENECA CHRONICLE (ASTHMA) OBSERVATIONAL

This study does not include any study drug. *Please note this study is only approved at the SE, EE, ET, DT, and CC office.
The purpose of this study is to collect information to help understand how doctors treat and mange people with severe asthma and how the health of people with severe asthma changes with those treatments.

Eligibility:

Medical records are collected every 6 months.
The length of each patient’s participation will vary but the goal is to have patients involved for 3 years or more.
Age > 18 years and older. Individuals with a diagnosis of severe asthma for at least 12 months prior enrollment.
Participants will complete monthly surveys via a dedicated website. An e-mail address will be required.

DBV TECHNOLOGIES (PEANUT ALLERGY) 4–7-YEAR-OLD CHILDREN WITH PEANUT ALLERGY

DBV712 provides epicutaneous immunotherapy (EPIT) using a dry deposit of a formulation of peanut protein extract, for the treatment of peanut allergy, (patch). This is a 12-month, Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of daily DBV712 250 μg.

Eligibility:

The study population is pediatric patients 4 to 7 years old with IgE-mediated peanut allergy, who have an eliciting dose (ED) of ≤ 100 mg peanut protein at study entry.
The overall maximum study duration for each subject is approximately 58 weeks: 4-week screening Period, 12-month Treatment Period and 2-week Follow-up Period.

SANOFI- ATLAS (LUNG FUNCTION DECLINE) ADULT > 18 YEARS OLD.

The primary objective of the study is to assess the effect of Dupilumab on preventing or slowing the rate of lung function decline .
The investigational medicinal product will be Dupilumab, or matching placebo supplied in a prefilled syringe to deliver 300 mg in a 2mL injection.
Dose regimen: every 2 weeks (Q2W) after initial loading dose of 600 mg (2 injections of 300 mg) on Day 1, given subcutaneous (SC).
Duration of study: Screening and run-in period up to 4 weeks, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Eligibility

Participant will need to have been diagnosed with asthma (according to GINA 2020) for > 12 months and treated with medium to high dose ICS (inhaled corticosteroid) in combination with a second controller (e.g., LABA (long-acting beta agonist), LTRA (leukotriene receptor antagonists) for at least 3 months with stable dose > 1month prior to visit 1. Additionally, need a History of > 1 exacerbation(s) in the previous year before Visit 1.

SCHEDULE APPOINTMENT: CALL 800.999.1249 OR SCHEDULE ONLINE

Current Research Studies

If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.

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